Vista Pharmaceuticals Warned on Facility Disrepair, Other Violations
FDA investigators visiting a Vista Pharmaceuticals plant in Nalgonda, India found equipment used to manufacture drugs riddled with holes and corrosion, according to a warning letter issued July 5.
Prior to the Sept. 19, 2016, inspection, FDA received a complaint about metal embedded in tablets, the letter said, and the agency criticized Vista for failing to determine the metal in the pills made at that site was due to the poor condition of the equipment.
Vista had not validated the production processes for its isoxsuprine hydrochloride USP 20 mg tablets, but had distributed a redacted number of batches to the United States from 2014 through 2016, the warning letter said. The FDA does not have an approved application on file for the isoxsuprine hydrochloride, the letter notes.